FDA Warns About Compounded Versions of Ozempic and Wegovy

FDA Warns About Compounded Versions of Ozempic and Wegovy

As of May 2023, both Ozempic and Wegovy were on the FDA's Drug Shortages list due to a global shortage of semaglutide.

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Ozempic was approved for the management of type 2 diabetes mellitus in adults in addition to a reduced-calorie diet and exercise. Wegovy, in conjunction with diet and exercise, is authorized to assist adults and children aged 12 years and older struggling with obesity, or some adults grappling with excess weight alongside weight-related medical conditions, in their efforts to lose weight and maintain their weight loss.

Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating. GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness.

As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide.

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. Drug compounding involves combining, mixing or altering ingredients to create customized medications for individual patients; however, compounded drugs are not FDA-approved, and their safety and efficacy are not validated.

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Why Is There a Semaglutide Shortage?

The recent surge in demand for Ozempic and Wegovy, driven largely by their perceived potential for weight loss touted on social media, has contributed to the semaglutide shortage. Many individuals are seeking these drugs solely for weight loss purposes, despite not having a medical necessity for them.

Novo Nordisk, the pharmaceutical manufacturer of Ozempic and Wegovy, is actively addressing these supply challenges. The company is currently producing and shipping all dosage strengths for Wegovy; however, it warns that limited quantities of 0.25 mg, 0.5 mg and 1 mg doses will be available to wholesalers for distribution to retail pharmacies. Despite this, Novo Nordisk doesn’t anticipate interruptions in supplying 1.7 mg and 2.4 mg doses of Wegovy.

Novo Nordisk reminds patients that Ozempic and Wegovy, despite having the same active ingredient, are distinct products with different indications, dosages, prescribing information and titration schedules. Therefore, they are not interchangeable. The company advises patients to consult their healthcare providers for specific guidance on the appropriate use of Ozempic and Wegovy based on their individual medical needs and conditions.

Safety Concerns with Compounded Semaglutide

Compounded drugs play a crucial role in providing treatment options for patients who cannot use FDA-approved medications due to various reasons, such as individual patient needs or drug shortages; however, compounded drugs lack the same level of safety, quality and efficacy assurances as approved drugs. The unnecessary use of compounded drugs can expose patients to potentially serious health risks.

There are safety concerns surrounding compounded semaglutide. Recent FDA investigations into adverse event reports associated with compounded semaglutide revealed that some compounders manufactured the drug in salt forms, such as semaglutide sodium and semaglutide acetate, which differ from the active ingredient in approved drugs. The approved drugs contain the base form of semaglutide. These salt forms have not been tested for safety and effectiveness.

What Should Patients and Healthcare Professionals Know?

Patients and healthcare professionals should understand that certain semaglutide products may not contain the same active ingredient as FDA-approved semaglutide. Instead, they may contain compounded semaglutide in salt forms, which could pose health risks. The FDA is not aware of any valid basis for compounding a drug using semaglutide salts that would meet federal requirements.

Patients are advised to discuss any concerns regarding these medications with healthcare providers or pharmacists.

Furthermore, patients should only purchase Ozempic, Wegovy or other medications from licensed healthcare providers or pharmacies. Buying medications from unregulated or unlicensed sources can expose individuals to potentially unsafe products that haven’t undergone proper evaluation, approval or quality standards. Healthcare professionals considering obtaining semaglutide products from compounders should be aware that these compounders might be using salt forms of semaglutide.

All healthcare professionals, patients and compounders are encouraged to report any adverse events or quality problems associated with these medications or other drugs to the FDA’s MedWatch Adverse Event Reporting program.